Country: Canada
Language: English
Source: Health Canada
ISOSORBIDE-5-MONONITRATE
JUNO PHARMACEUTICALS CORP.
C01DA14
ISOSORBIDE MONONITRATE
60MG
TABLET (EXTENDED-RELEASE)
ISOSORBIDE-5-MONONITRATE 60MG
ORAL
30/100
Ethical
NITRATES AND NITRITES
Active ingredient group (AIG) number: 0120456002; AHFS:
APPROVED
2018-08-03
PRODUCT MONOGRAPH IMDUR ® (isosorbide-5-mononitrate extended release tablets) 60 mg extended release tablets Antianginal Agent Juno Pharmaceuticals Corp. 402-2233 Argentia Road Mississauga, Ontario L5N 2X7 Date of Revision: September 11, 2020 Submission Control Number: 242735 - 1 - PRODUCT MONOGRAPH NAME OF DRUG IMDUR ® (isosorbide-5-mononitrate extended release tablets) 60 mg extended release tablets THERAPEUTIC CLASSIFICATION Antianginal agent ACTIONS AND CLINICAL PHARMACOLOGY As with other organic nitrates, the principal pharmacological action of IMDUR (isosorbide-5- mononitrate), the major active metabolite of isosorbide dinitrate (ISDN), is relaxation of vascular smooth muscle and consequent dilation of peripheral arteries and veins, especially the latter. Dilation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (pre-load). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (after-load). Dilation of the coronary arteries also occurs. The hemodynamic responses to isosorbide-5-mononitrate are similar to those produced by other nitrates. PHARMACODYNAMICS Dosage regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Prolonged administration of nitrate drugs according to traditionally recommended dosage regimens has been shown to produce tolerance. Tolerance results in a loss of efficacy. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously delivered nitrates. In the large majority of these trials, nitrate effectiveness was indistinguishable from placebo after 24 hours (or less) of continuous therapy. Attempts to overcome tolerance by dose escalation, even to doses far in excess of those used Read the complete document